Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial

• Published in: BMJ open Vol. 5; no. 12; p. e008283
• Main Authors: Barnhoorn, Karlijn J, van de Meent, Henk, van Dongen, Robert T M, Klomp, Frank P, Groenewoud, Hans, Samwel, Han, Nijhuis-van der Sanden, Maria W G, Frölke, Jan Paul M, Staal, J Bart
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01-12-2015; BMJ Publishing Group
• Subjects: Adult; Analgesics; Complex Regional Pain Syndromes - diagnosis; Complex Regional Pain Syndromes - therapy; Family physicians; Female; Free radicals; Humans; Intention to Treat Analysis; Intervention; Male; Medical dressings; Middle Aged; Mobility; Muscle strength; Occupational therapy; Orthopedic apparatus; Pain; Pain Measurement; Patient Compliance; Performance evaluation; Physical therapists; Physical therapy; Physical Therapy Modalities - adverse effects; Prospective Studies; Rehabilitation Medicine; Single-Blind Method; Sports training; Strength training; Transcutaneous electrical nerve stimulation-TENS; Treatment Outcome; Netherlands; PAIN MANAGEMENT; REHABILITATION MEDICINE
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2015-008283

ObjectiveTo compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor.SettingThe study was conducted at a level 1 trauma centre in the Netherlands.Participants56 adult patients with CRPS-1 participated. Three patients were lost to follow-up.InterventionsPatients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline.MeasurementsOutcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score—Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D.ResultsThe intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI −1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG.ConclusionsWe cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis.Trial registration numbersNCT00817128 and NTR 2090.